Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.

The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.

Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Drug: Bevacizumab	Phase 4

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Study Start Date :	July 2008
Estimated Primary Completion Date :	December 2011
Estimated Study Completion Date :	June 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: standard of care; standard of care for trabeculectomy surgery	Drug: Bevacizumab; single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery; Other Name: Avastin
Active Comparator: bevacizumab arm	Drug: Bevacizumab; single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery; Other Name: Avastin

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. post surgery IOP (Intra Ocular Pressure Measurement) [ Time Frame: one year post surgery ]

Secondary Outcome Measures :

1. bleb appearance [ Time Frame: one year post surgery ]
2. number of bleb needlings [ Time Frame: one year post surgery ]
3. number of glaucoma medications at 12 months postoperatively [ Time Frame: one year post surgery ]
4. eye complications [ Time Frame: one year post surgery ]
5. systemic complications [ Time Frame: one year post surgery ]
6. need for another glaucoma surgery to control glaucoma [ Time Frame: one year post surgery ]
7. postoperative visual acuity at 12 months [ Time Frame: 12 months post surgery ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• any type of glaucoma, except neovascular or inflammatory
• patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery

Exclusion Criteria:

• younger than 30 years of age
• previous ocular surgeries excepting cataract surgeries
• patients who have had or present with intraocular inflammation
• neovascular glaucoma
• patients who are aphakic
• diabetic retinopathy

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lesya Shuba, MD, PhD	902 473-3410	lshuba@dal.ca
Contact: Mimi Stanfield, BA	901 473-3236	stanfieldmj@dal.ca

Locations

Canada, Nova Scotia
CDHA	Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9

Sponsors and Collaborators

Nova Scotia Health Authority

Investigators

Principal Investigator:	Lesya Shuba, MD PhD	CDHA Halifax Nova Scotia Canada

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lesya Shuba MD FRCSC PhD, Capital District Health Authority, Halifax, Nova Scotia,Canada
ClinicalTrials.gov Identifier:	NCT01229202 History of Changes
Other Study ID Numbers:	CD-2007-331
First Posted:	October 27, 2010
Last Update Posted:	July 1, 2011
Last Verified:	June 2011

Keywords provided by Nova Scotia Health Authority:

trabeculectomy; glaucoma surgery; bevacizumab; Vascular Endothelial Growth Inhibitor; glaucoma

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases; Bevacizumab; Endothelial Growth Factors; Angiogenesis Inhibitors	Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents